Early Access Program for Zolbetuximab

Launched by ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. · Sep 15, 2023

Keywords

ClinConnect Summary

The European Union European Medicines Agency, the United States Food and Drug Administration, and South Korea Pharmaceuticals and Medical Devices Agency have approved zolbetuximab for the treatment of advanced stomach/GEJ cancer in adults. Enrollment is closed in United States, and Germany.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient has histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
• • Patient has confirmed locally advanced, unresectable or metastatic gastric or GEJ adenocarcinoma.
• • Patient whose tumor expresses claudin18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central immunohistochemistry (IHC) testing.
• • Patient has a Human epidermal growth factor receptor 2 (HER2-negative) tumor by local testing on a gastric or GEJ tumor specimen.
• • Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• • Patient must meet all of the following criteria based on the locally analyzed laboratory tests collected.
• • Hemoglobin (Hgb) ≥ 9 g/dL. Patients requiring transfusions are eligible if they have post-transfusion Hgb ≥ 9 g/dL.
• • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• • Platelets ≥ 100 × 109/L
• • Albumin ≥ 2.5 g/dL
• • Total bilirubin (TBL) ≤ 1.5 × ULN without liver metastases (or \< 3.0 × ULN if liver metastases are present)
• • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) without liver metastases (or ≤ 5 × ULN if liver metastases are present)
• • Estimated creatinine clearance ≥ 30 mL/min
• • Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time ≤ 1.5 × ULN (except for patients receiving anticoagulation therapy)
• * Female patient is not pregnant and at least 1 of the following conditions apply:
• • Not a woman of child bearing potential (WOCBP)
• • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final administration of oxaliplatin and 6 months after final administration of other interventions.
• • Female patient must agree not to breastfeed starting at screening and throughout the EAP period and for 6 months after final intervention administration.
• • Female patient must not donate ova starting at first administration of treatment and throughout the EAP period and for 9 months after the final administration of oxaliplatin and 6 months after final administration of other interventions.
• • Male patient with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after final treatment administration.
• • Male patient must not donate sperm during the treatment period and for 6 months after final treatment administration.
• • Male patient with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the EAP period and for 6 months after final treatment administration.
• Exclusion Criteria:
• • Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab.
• • Patient is a candidate for an ongoing clinical trial of zolbetuximab.
• • Patient has received any investigational therapy within 28 days or 5 half-lives prior to screening.
• • Patient has a known or suspected hypersensitivity to zolbetuximab, other monoclonal antibodies or any components of the formulation used.
• • Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, patient may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to participation.
• • Patient has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to program registration and has not recovered from any related toxicity.
• • Patient receiving treatment with herbal medications that have known antitumor activity.
• • Patient has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to registration. Patients using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg/day of hydrocortisone or up to 10 mg/day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.
• • Patient has a prior severe allergic reaction, known (immediate or delayed) or suspected hypersensitivity, intolerance or contraindication to zolbetuximab, mFOLFOX6, CAPOX, other monoclonal antibodies or any components of the formulations used.
• • Patient has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screening for DPD deficiency should be conducted per local requirements.)
• • Patient has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
• • Patient has significant gastric bleeding and/or untreated gastric ulcers that would exclude the patient from participation.
• • Patient has any other condition, which makes the patient unsuitable to receive or tolerate zolbetuximab.